@article{31e54883f4214509a0ae4145589b4942,
title = "Characterization of Anaphylaxis After Ecallantide Treatment of Hereditary Angioedema Attacks",
abstract = "Background: Ecallantide is a human plasma kallikrein inhibitor indicated for treatment of acute attacks of hereditary angioedema for patients 12 years of age and older. Ecallantide is produced in Pichia pastoris yeast cells by recombinant DNA technology. Use of ecallantide has been associated with a risk of hypersensitivity reactions, including anaphylaxis. Objective: The objective of this detailed retrospective data review was to characterize anaphylaxis cases within the ecallantide clinical trials database. Methods: Potential cases of hypersensitivity reactions in the ecallantide clinical development program were identified by examining reported adverse events. The National Institute of Allergy and Infectious Disease criteria were used to identify those events that were consistent with anaphylaxis; these cases were then reviewed in detail. Results from investigational antibody testing also were examined. Results: Among patients who received subcutaneous ecallantide (n= 230 patients; 1045 doses of 30 mg ecallantide), 8 patients (3.5%) had reactions that met the National Institute of Allergy and Infectious Disease criteria for anaphylaxis; none occurred on first exposure to the drug. All 8 reactions had symptom onset within 1 hour of exposure and cutaneous manifestations commonly observed in type I hypersensitivity reactions. All the reactions responded to standard management of type I hypersensitivity reactions and resolved without fatal outcomes. IgE antibody testing to ecallantide or P pastoris was not consistently positive in patients who experienced apparent type I hypersensitivity reactions. Conclusion: Anaphylaxis episodes after subcutaneous ecallantide exposure have clinical features suggestive of type I hypersensitivity reactions. However, anti-ecallantide or anti- P pastoris IgE antibody status was not found to be reliably associated with anaphylaxis.",
keywords = "Allergy, Anaphylaxis, Ecallantide, HAE, Hereditary angioedema, Hypersensitivity",
author = "Craig, {Timothy J.} and Li, {H. Henry} and Marc Riedl and Bernstein, {Jonathan A.} and Lumry, {William R.} and MacGinnitie, {Andrew J.} and Stolz, {Leslie E.} and Joseph Biedenkapp and Yung Chyung",
note = "Funding Information: Conflicts of interest: T. J. Craig is an American Academy of Allergy, Asthma & Immunology Interest section leader; past board member for American College of Allergy, Asthma & Immunology, American Lung Association of Pennsylvania, and Joint Council of Allergy, Asthma and Immunology; has received consultancy fees from CSL Behring, Dyax, Viropharma, Shire, Merck, Biocryst, Bellrose, Merck; has received research support from Viropharma, CSL Behring, Shire, Dyax, Pharming, Merck, Genentech, GlaxoSmithKline, Grifols, Novartis, Sanofi Aventis, and Boehringer Ingelheim; has received lecture fees from CSL Behring, Dyax, Shire, and Grifols; and is co-investigator of Asthmanet, National Heart, Lung and Blood Institute. H. H. Li has received consultancy fees from Salix, Shire/Viropharma, CSL Behring, and Dyax; has received research support from Shire/Viropharma ; has received lecture fees from Shire/Viropharma, CSL Behring, and Dyax. M. Riedl has received consultancy fees from CSL Behring, Dyax, Shire, Isis, Biocryst, and Santarus; has received research support from CSL Behring , Dyax , Shire , Pharming , and BioCryst ; has received lecture fees from CSL Behring, Dyax, and Shire. J. A. Bernstein was a principal investigator for clinical trials for, has received consultancy and lecture fees, and research support from Dyax , Shire/Viropharma , CSL Behring , and Pharming ; is on the United States Hereditary Angioedema Association medical advisory board and editorial board of The Journal of Angioedema. W. R. Lumry has received research support from Dyax , CSL Behring , Shire/Viropharma , and Pharming ; has received consultancy fees from Dyax, Biocryst, CSL Behring, and Shire/Viropharma; has received fees for participation in review activities from Biocryst; and has provided review of medical records for the Steed Law firm. A. J. MacGinnitie has received consultancy fees from Dyax, CSL Behring, and Viropharma; and has received research support from Shire . L. E. Stolz and J. Biedenkapp are employed by Dyax. Y. Chyung is employed by and owns stock/stock options in Dyax. Publisher Copyright: {\textcopyright} 2014 The Authors. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",
year = "2015",
month = mar,
day = "1",
doi = "10.1016/j.jaip.2014.09.001",
language = "English (US)",
volume = "3",
pages = "206--212.e4",
journal = "Journal of Allergy and Clinical Immunology: In Practice",
issn = "2213-2198",
publisher = "Elsevier",
number = "2",
}